# FDA 483 - KL Distributing - October 27, 2022

Source: https://www.keypedia.com/records/483/kl-distributing/3882b377-96f2-4568-b064-001a2abcc85b

> FDA 483 for KL Distributing on October 27, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: KL Distributing
- Inspection Date: 2022-10-27
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: KL Distributing, a medical device specification developer in Hudson, FL, received an FDA Form 483 citing multiple quality system deficiencies. The inspection revealed inadequate procedures for purchasing controls, personnel training, and document control. Additionally, the firm's Medical Device Reporting procedures were incomplete, and top management failed to establish a quality policy or appoint a management representative.

## Related Officers

- [investigator](https://www.keypedia.com/people/stanley-b-eugene/4708f43e-0592-4c24-b276-d9f9092788a3)

Company: https://www.keypedia.com/companies/kl-distributing/4f3b0acb-1077-442d-97b5-d72fa7a25ae0

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6